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The pAguaMedicina™ PERSISTENT™ Structural Hydrogel Ureteral Stent is used to facilitate drainage from the kidney to the bladder and stenting of the ureter in patients not less than 2 years old. The Stent may be placed using endoscopic, percutaneous or open surgical techniques. The Stent should not be implanted for more than 30 days. This product is not intended as a permanent indwelling device.

The pAguaMedicina™ PERSISTENT™ Structural Hydrogel Ureteral Stent meets the statutory definition of 21 CFR 876.4620 as a "tube-like", implanted device that is inserted into the ureter to provide ureteral rigidity and allow the passage of urine. Ureteral stents may have finger-like protrusions or hooked ends to keep the tube in place. They are used in the treatment of ureteral injuries and ureteral obstruction. The purpose of this Special 510(k) is to expand the product line of the pAguaMedicina™ PERSISTENT™ Structural Hydrogel Ureteral Stent [510(k) K163068], to add variations in anchorage profile. The recommended usage of the pAguaMedicina™ PERSISTENTTM Structural Hydrogel Ureteral Stent, to facilitate drainage from the kidney to the bladder and stenting of the ureter in patients not less than 2 years old, remains unchanged. Particular uses and the choice of anchorage profile are left to the physician's discretion and suggestions do not appear in the labeling. The labeling will only identify the type of anchorage profile. All stents are radiopaque. All stents by Q Urological TM Corporation are single use, sterile devices, administrated in healthcare facilities by prescription. As with the cleared / predicate pAguaMedicina™ PERSISTENT™ Structural Hydrogel Ureteral Stent, the modified stent may be placed using endoscopic, percutaneous, or open surgical techniques. The stent should not be implanted for more than 30 days. The product is not intended as a permanent indwelling device. The proposed stents will be made of the same material as the predicate (trademark paguamedicina™), a partiality hydrolyzed polyacrylonitrile, produced in part from a proprietary manufacturing process. The modified device incorporates a wire form which creates a pigtail configuration upon deployment. The wire is composed of metals that have been implanted in the human body in a wide variety of locations (tissue and bone), for numerous applications and are considered to be biocompatible. The manufacturing methods, process parameters, design controls and quality assurance system (QSR - 21 CFR 820) used for all pAguaMedicina™ PERSISTENT™ Structural Hydrogel Ureteral Stents are the same as those of the cleared / predicate device; [510(k) K163068]. The stents are sterilized by E Beam radiation to a sterility assurance level of 10-6.

This document, a Special 510(k) Summary for the pAguaMedicina™ PERSISTENT™ Structural Hydrogel Ureteral Stent, primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device (K163068) for an expanded product line with modified anchorage profiles. It explicitly states that "No non-clinical or clinical performance data are included in this Special 510(k)." Therefore, based only on the provided text, it's not possible to provide details on acceptance criteria and a study that proves the device meets them in the traditional sense of a clinical or non-clinical performance study with specific metrics and results.

Instead, the submission relies on the concept of design controls, verification, and validation activities to establish substantial equivalence to the predicate device, implying that the modifications do not introduce new questions of safety or effectiveness.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

As stated above, the document explicitly says "No non-clinical or clinical performance data are included in this Special 510(k)." Therefore, a table of specific acceptance criteria and reported device performance (e.g., success rates, complication rates, specific measurements) is not present in this submission. The "performance" is implicitly tied to the predicate device's established performance and the assertion that the new variations maintain that safety and effectiveness.

The document's argument for substantial equivalence is based on:

• Intended Use and Indications for Use: Unchanged from the predicate.
• Material: Same raw material (paguamedicina™) as the predicate.
• Manufacturing Methods, Process Parameters, Design Controls, and Quality Assurance System (QSR): Same as the predicate.
• Sterilization Method: Same (E Beam radiation to a sterility assurance level of 10-6).
• Labeling: Consistent with the predicate, with revisions only to reflect the particular anchorage profile.
• Validation and Verification Activities: Performed under Design Controls to assess individual risk analysis, concluding that differences in attributes for modified anchorage configurations do not introduce "any different questions of safety and effectiveness" from the predicate.

2. Sample Size Used for the Test Set and Data Provenance:

Not applicable, as no non-clinical or clinical performance data from a "test set" are presented in this submission. The substantial equivalence argument relies on design controls and equivalence to a previously cleared device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

Not applicable for the reasons stated above.

4. Adjudication Method for the Test Set:

Not applicable for the reasons stated above.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. This submission does not mention or present any MRMC studies.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a physical medical device (ureteral stent), not an algorithm or AI product.

7. The Type of Ground Truth Used:

Not applicable for a performance study in this submission. For the predicate device, the "ground truth" for its clearance would have been established through its own clinical and non-clinical data, which is not detailed here. In this Special 510(k), the "ground truth" for substantial equivalence is the established safety and effectiveness of the predicate device (K163068).

8. The Sample Size for the Training Set:

Not applicable, as this is not an AI/algorithm device submission, nor does it present new performance study data.

9. How the Ground Truth for the Training Set was Established:

Not applicable for the same reasons as above.

In summary:

This Special 510(k) relies on demonstrating that modifications (new anchorage profiles) to an already cleared device do not alter its fundamental safety and effectiveness profile. The "study" proving the device meets acceptance criteria is implicitly the design control process, verification, and validation activities performed to ensure that the modified devices are substantially equivalent to the predicate, which itself would have undergone performance testing. The document explicitly states that it does not include new non-clinical or clinical performance data to directly prove acceptance criteria for the modified devices.

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